Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Study information

Scientific title

SARAH: Stretching and Strengthening for Rheumatoid Arthritis of the Hand: the clinical and cost effectiveness of an exercise programme over and above usual care

Acronym

SARAH

Study hypothesis

1. To estimate the clinical effectiveness of adding an optimised exercise programme for hands and upper limbs in addition to standard care, joint protection, in the reduction of hand dysfunction and pain for patients with rheumatoid arthritis2. To estimate the cost-effectiveness of adding this programme to usual care3. To describe, qualitatively, the experience on participants in the trial with a particular emphasis on patient expectation, exercise behaviours, and reasons for adherence/non-adherence

Ethics approval

Oxfordshire Research Ethics Committee C, 10/06/2008, ref: 08/H060/47

Study design

Pragmatic randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Rheumatoid arthritis affecting the hands and wrists

Intervention

Participants will be randomly allocated to the intervention and control groups.

In addition to the participants receiving conventional care we are proposing to implement a programme of exercise therapy to increase hand function using functional exercises to stretch and strengthen the muscles and tendons, also to mobilise the joints of the hand and wrist and improve dexterity. The programme will entail six half-hour appointments spread over 12 weeks. This number of contacts, spread over this epoch, will allow sufficient progression of the intensity of exercise and physiological response in the neuromuscular system to significantly improve function. The exercise programme was developed following a professional consensus of UK physiotherapists/occupational therapists and has some evidence of short-term effectiveness. We are proposing a number of additional elements designed to increase long-term effectiveness. The intervention will use a standardised protocol of progression and reduction of exercise intensity.

1. Specific Functional Exercise: Our exercise programme will use sound exercise principles to improve strength, mobility and dexterity whilst performing functional tasks. 2. Progressive Resistance Training: Participants will be provided with elastic resistance bands (Theratube, Akron, USA) that provide this resistance and can progressively increase demand. 3. Mobility Exercise: The tendon sheaths of patients with RA hands are known to suffer from adhesions and consequently specific 'tendon sliding' exercises have been developed that target movements of the wrist and fingers in combination to maintain full mobility of the flexor and extensor tendons and will be incorporated into the programme. People with hand RA frequently have deformity of the hands and wrists that make the placement of their hands into positions for efficient function difficult. Additionally, people with RA can develop restriction of movement of the elbows and shoulders as well as the hands. Thus, as the function of the hand is associated with the ability to position and maintain the hand in space, the exercise programme will also include mobility exercise of all the upper limbs joints. 4. Dexterity Exercise: Functional tasks demanding increasing dexterity will be introduced in stages and the performance of tasks timed and critiqued. 5. Home Exercise: The number of home exercises and the demand of dexterity tasks will be progressively increased to ensure the intensity of home exercise is adequate to overload the muscular system and challenge sensori-motor control. Targets for home exercise will be based on individual assessment of performance and progressed at four, eight and twelve weeks. 6. Adherence with Home Exercise: We aim to maximise adherence to the prescribed exercise regimen through a two-stage mechanism that distinguishes between motivational and volitional phases of behaviour.

The programme will entail six half-hour appointments spread over 12 weeks. Exercise will be provided individually by a physiotherapist.

The following secondary outcome measure was added as of 10/07/2008: 14. Adherence to home exercise, assessed at 3 and 12 months

Overall trial start date

01/11/2008

Overall trial end date

30/04/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. People with RA2. Those who meet the American College of Rheumatology clinical and immunological criteria, with pain and dysfunction of the hands and or wrist joints3. Either not on a Disease-Modifying Anti-Rheumatic Drugs (DMARD), or who have been on a stable DMARD regimen, for three months or more

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

480

Participant exclusion criteria

1. Patients recovering from upper limb joint surgery, or fracture, in the previous six months2. Patients on a waiting list for upper limb orthopaedic surgery3. Patients who are pregnant4. Aged less than 18 years

Additional files

Editorial Notes

18/04/2017: Publication reference added.
21/08/2009: The overall trial start and end dates were changed from 01/09/2008 and 31/03/2012 to 01/11/2008 and 30/04/2012, respectively.
26/06/2008: The public title was changed from "SARAH: Strengthening in Rheumatoid Arthritis of the Hand" to the current title.